Catheters are used during many medical procedures in the gastrointestinal system, including the pancreatobiliary system (i.e., the biliary tree), the stomach, and the esophagus. During vascular procedures, such as balloon angioplasty, stent placement, and endoluminal grafts for aortic aneurysms, the use of catheters are essential in evaluating the site of the particular obstruction in the affected artery. For example, catheters are inserted into canals, vessels, and passageways of the body to permit injection or withdrawal of fluids, or to keep the passageway open. Catheters also provide access to a passageway of the patient while a physician performs various procedures. For example, catheters are often utilized to perform varying medical procedures, such as the deployment of stents and biopsy procedures.
Catheters are also inserted through endoscopes during the diagnosis and treatment of several medical conditions. One such medical procedure utilizing a catheter device is Endoscopic Retrograde Cholangiopancreatography (ERCP). During ERCP procedures the catheter tends to experience many difficulties due to the various functions of the particular catheter. For example, during procedures involving identifying obstructions within the biliary or pancreatic duct, a catheter may be utilized to insert a wire guide and advance other medical devices over the wire guide. Additionally, the catheter may be utilized to pass contrast medium to identify obstructions such as bile duct stones. The catheter may also be utilized for flushing or passing fluids. Regardless of the medical procedure performed, the catheter can experience problems associated with friction or the leakage of bodily fluids due to the constant removal and insertion of medical devices through the catheter or the use of multiple catheters.
Due to the complexity of the particular medical procedure, physicians often need to insert additional medical devices through the catheter (or the endoscope) during the medical procedure. Thus, many medical procedures often require the use of two or more catheters and catheter exchanges. However, due to the difficulty associated with catheter exchanges and the time associated with the insertion and removal of medical devices into the catheter, the task of positioning and maneuvering medical devices through the catheter or the positioning of multiple catheters can become difficult and time consuming. Additionally, catheter exchanges tend to shift the focus of the assistant from other areas of responsibility, such as checking the patient, checking monitors for relevant information, or carrying out other tasks.
As a way of simplifying procedures involving catheters, devices have been developed that include multiple lumen combinations. One device includes a multiple lumen catheter that requires a first, a second, and a third lumen wherein each lumen functions respectively to inject a contrast agent, perform a sphincteromy and dislodge gallstones. The lumens of the catheter extend parallel to each other between a proximal and distal end of the device. A problem with this type of device is that the lumen sizes of the catheter are restricted and the functionality of the device is limited to particular medical procedures. As a result of the size limitations of the lumens of the catheter, it is difficult to pass flushing fluids within the lumens of the catheter. Specifically, the space between the lumens of the catheter is not large enough to create the necessary hydraulic force for properly removing gallstones or similar objects. Therefore, the lumens of the catheter may become clogged during use thereby preventing the removal of gallstones or similar dislodged objects with the device.
Another catheter device available in the prior art includes the use of balloons in the removal of common bile duct stones. This type of device includes a catheter balloon that is passed beyond the stones and then positioned adjacent to the upstream side of the stones. Once positioned, the catheter balloon is inflated and the entire assembly is withdrawn outwardly until the stone has been pulled out through an incision in the common duct. The catheter utilizes the balloon for the purpose of removing stones from the common bile duct by retrograde movement of the stone through the incision in the common duct. However, use of this type of catheter device can become time consuming and inconvenient because of the time associated with performing the medical procedure using this complex assembly, and the increased risk resulting from removing stones through an incision.
What is needed is a catheter device that allows medical devices to be quickly and easily inserted into the gastrointestinal system for flushing the biliary duct of a patient, reduces the need for multiple catheter exchanges, and requires minimal time for a physician to operate and perform functions during the removal of obstructions within the biliary duct of a patient.